CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation

NCT06355063 | Recruiting FDA Device

• 2 other identifiers: NP-PCF-037NCT06355063
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 6

Brief Summary

This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure.

Conditions

Atrial Fibrillation; Clamp Study; Ablation of Atrial Fibrillation; Surgery

Keywords

CellFX; nsPFA Cardiac Surgery System

Outcome Measures

Primary Outcomes (2)

• Rate of acute major adverse events (MAEs)

  Acute major adverse events (MAEs) include, cardiac death, stroke, myocardial infarction, transient ischemic attack, or excessive bleeding.

  Within 30 days post-ablation procedure

• Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial box

  The ablation procedure includes pulmonary vein isolation and a series of ablation lines to create a "box lesion" on the posterior left atrial free wall. At the conclusion of both the primary and concomitant procedures, exit and/or entrance block will be performed to confirm complete isolation of the pulmonary veins and the left atrial posterior wall.

  Within 24 hours post-ablation procedure

Secondary Outcomes (2)

• Proportion of Participants with one or more SAEs

  Up to 12-months post-procedure

• Number of Participants with Long-Term Technical Success

  60-120 days following the index procedure

Study Arms (1)

CellFX nsPFA Treatment Arm

EXPERIMENTAL

Adult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein, roof and floor ablations to form a left atrial posterior box using the CellFX® nsPFA™ Cardiac Surgery System.

Device: CellFX® nsPFA™ Cardiac Surgery System

Interventions

CellFX® nsPFA™ Cardiac Surgery System DEVICE

Adult patients presenting to the investigational center that are to undergo non-emergent concomitant cardiac surgical procedure(s), scheduled to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, ascending aortic aneurysms, or coronary artery bypass procedures with history of documented atrial fibrillation within one year prior to enrollment will be evaluated for eligibility and participation in the study.

CellFX nsPFA Treatment Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be between 18 and 85 years of age
• Subject is willing and capable of providing Informed Consent to undergo study procedures which includes surgical AF ablation and completing follow-up visits as specified in the clinical study protocol
• Subject has history of documented atrial fibrillation within one year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), holter monitor or telemetry strip
• Subject is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Ascending aortic aneurysms, or Coronary artery bypass procedures
• Left ventricular ejection fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)
• Subject has a life expectancy of at least 5 years

You may not qualify if:

• Subject has an implantable electronic medical device. (i.e., pacemaker, ICD or CRT) or left atrial appendage device
• Subject has a prosthetic heart valve
• Stand-alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
• Previous surgical Maze procedure
• Prior cardiac surgery (Redo)
• Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, Atrioventricular (AV) nodal reentry
• Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or atrial septal defect repair.
• Prior history of medical procedure involving instrumentation of the left atrium (e.g., previous ablation)
• Class IV New York Heart Association (NYHA) heart failure symptoms
• Prior history of cerebrovascular accident or TIA within 6 months or at any time if there is residual neurological deficit
• Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment
• Need for emergent cardiac surgery (i.e., cardiogenic shock)
• Known carotid artery stenosis greater than 80%
• Current diagnosis of active systemic infection
• Severe peripheral arterial occlusive disease defined as claudication with minimal exertion

Sponsors & Collaborators

• Pulse Biosciences, Inc.: lead
• Avania: collaborator

Study Sites (6)

Medical University of Vienna

Vienna, Austria

RECRUITING

Academic Medical Center

Amsterdam, Netherlands

ACTIVE NOT RECRUITING

Catharina Hospital

Eindhoven, Netherlands

RECRUITING

Maastricht University Medical Center+ (MUMC+)

Maastricht, Netherlands

ACTIVE NOT RECRUITING

St. Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

State Medical Institute of the Ministry of Interior Affairs and Administration

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rich Nuccitelli, PhD

  Pulse Biosciences, Inc.

  STUDY DIRECTOR

Central Study Contacts

William A. Knape

CONTACT

+1 (919) 757-2033; bknape@pulsebiosciences.com

Aleksandra Kurek

CONTACT

+44 745 6655949; aleksandra.kurek@pulsebiosciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a prospective, multicenter, single arm, non-randomized, feasibility study.

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 9, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); NL (4); PL (1)